Remote Enhanced Assessment for Care at Home (REACH) (REACH)

June 1, 2026 updated by: Kristin Ray, University of Pittsburgh

Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility Trial

The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.

The main question it aims to answer are:

- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.

Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will prospectively enroll 100 children (6 month 0 days to 8 months 30 days) in this one-arm pilot feasibility study. Enrolled participants will receive kits including pulse oximeters, thermometers, and tele-otoscopes as well as respiratory viral swab tests and will complete a test call with study team members to confirm ability to connect and use the devices.

After enrollment, families will continue to seek care based on their own preferences and primary care clinic guidance, but will have the ability to provide additional information to their primary care clinicians when primary care telemedicine visits occur.

The investigators will ask families to complete online surveys at 0, 30, and 180 days, and the investigators will perform chart reviews to capture visits (telemedicine and in-person to primary care, urgent care, and emergency department) and antibiotic receipt.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Children's Hospital of Pittsburgh Primary Care Center
      • Pittsburgh, Pennsylvania, United States, 15234
        • UPMC Children's Community Pediatrics - Castle Shannon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants receiving care at study sites presenting for primary care child visit
  • Infants between 6m0d and 20m30d

Exclusion Criteria:

  • Caregiver not able to consent in English or Spanish
  • Child has chronic condition (prematurity <33 weeks, congenital anomaly)
  • Child is ward of the state
  • Family lacks device and/or wifi plan to be able to participate in telemedicine visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tele-Device Kit Arm
Families of 6 month old infants will receive tele-device kits that include thermometers, pulse oximeters, and tele-otoscopes and respiratory swab tests, which families will then have the option to use when they schedule telemedicine visits with their usual primary care practice.
Other: Remote Enhanced Assessment for Care at Home (REACH) Kit

Families of 6 month old infants will receive tele-device kits that include thermometers, pulse oximeters, and tele-otoscopes and respiratory swab tests, which families will then have the option to use when they schedule telemedicine visits with their usual primary care practice.

Note that the investigators are not studying the devices themselves; the investigators are instead studying health care use and experiences when these devices are made available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: From enrollment to survey completed 6 months after enrollment, up to 18 months
Percent who complete 6 months survey
From enrollment to survey completed 6 months after enrollment, up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: Day approached for recruitment, up to one year
Percent of individuals approached who consent
Day approached for recruitment, up to one year
Caregiver Satisfaction
Time Frame: From enrollment to survey completed 6 months after enrollment, up to 18 months
Caregiver satisfaction with care using the tele-device kit as reported at 6 month survey. Satisfaction will be assessed a single Likert scale survey item, ranging from 0 to 4, with higher scores indicating greater satisfaction with care.
From enrollment to survey completed 6 months after enrollment, up to 18 months
Kit utilization
Time Frame: From enrollment to survey completed 6 months after enrollment
Number of primary care telemedicine visits where kit devices are and are not used, assessed through both survey and through chart review.
From enrollment to survey completed 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Kristin Ray, MD, MS, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Actual)

May 28, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24110038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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